Description

Isotretinoin Ep Impurity C is a high-purity reference standard used for analytical and quality control purposes in the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of isotretinoin-based drug products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for analytical chemists, quality assurance professionals, and research scientists working in pharmaceutical development and manufacturing. The product is supplied with comprehensive analytical data to support regulatory filings and in-house quality systems.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling: Critical for the identification and quantification of Isotretinoin Ep Impurity C in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development & Validation: Used in the development and validation of HPLC, UPLC, and GC methods for impurity analysis in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of isotretinoin to understand impurity formation pathways.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC testing of isotretinoin API to ensure batch-to-batch consistency and purity.
• Research & Development: Used in synthetic chemistry research to study the formation and fate of this specific impurity during the manufacturing process.

Basic Information

Product Name	Isotretinoin Ep Impurity C
CAS No.	3555-80-4
Molecular Formula	C20H28O2
Molecular Weight	300.44 g/mol
Synonyms	13-cis-Retinoic Acid Impurity C; Isotretinoin Related Compound C; (2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic Acid; 13-cis-Retinoic Acid EP Impurity C; Tretinoin Impurity; Retinoic Acid Isomer Impurity
EINECS	Contact for details

Quality Control

Every batch of Isotretinoin Ep Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using validated analytical methods (e.g., HPLC, NMR, MS) to confirm identity, purity, and strength. We provide comprehensive Certificates of Analysis (COA) that include batch-specific results for all critical parameters. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting your compliance with cGMP, ICH, USP, and EP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.